|By PR Newswire||
|April 2, 2014 09:15 AM EDT||
HARRISBURG, Pa., April 2, 2014 /PRNewswire-iReach/ -- Results from a groundbreaking study performed at PinnacleHealth were revealed this weekend at the American College of Cardiology's 2014 Scientific Sessions and simultaneously published in The New England Journal of Medicine.
"In patients with aortic valve stenosis, the self-expanding transaortic transcatheter aortic valve bioprosthesis implant, was associated with a significantly higher rate of survival after one year, than open heart surgical aortic valve replacement," states Brijeshwar Maini, MD, FACC, medical director of the PinnacleHealth Heart Valve Clinic.
Patients at PinnacleHealth Heart Valve Clinic participated in the Medtronic CoreValve® U.S. Pivotal Trial, which compared transcatheter aortic valve replacement (TAVR) using a self-expanding bioprosthesis to open heart surgical aortic valve replacement in patients with severe aortic stenosis, who are at "high risk" for surgery.
This is the first time a prospective, randomized study has shown transcatheter aortic valve replacement to be superior to open heart surgery. Patients in the trial had narrowed, failing aortic heart valves, called severe aortic stenosis.
In the study, physicians replaced diseased aortic valves in 747 patients, approximately half of who were randomized to the new minimally invasive CoreValve System, and half of whom were randomized to open heart surgery. The all-cause mortality rate was 14.2 percent in patients receiving the CoreValve System, compared to 19.1 percent in patients receiving surgery, a statistically significant finding at one year (the primary endpoint of the trial).
The rate of stroke, one of the complications most concerning to physicians and patients due to increased mortality, was low and produced similar results between the two groups of patients.
Patients also saw significant improvements in their quality of life. Quality of Life scores improved 19.0 points for CoreValve patients and 3.7 points for surgical patients at 30 days, and at one year both patient groups improved significantly, with CoreValve patients improving 23.2 points and surgical patients improving 21.9 points - as measured by Kansas City Cardiomyopathy Questionnaire (KCCQ) 100-point scale, where five points is considered improvement, and 20 points is considered a very large improvement.
"The CoreValve System is designed with self-expandable technology to replace a diseased aortic valve. It is placed percutaneously, meaning through the skin, usually through a small opening in the femoral artery, without open heart surgery or removal of the original valve. We then guide it into the heart at the site of the original aortic valve. Once in place, it takes over the original aortic valve's function and ensures that blood flows out of the heart freely without any obstruction," explains Dr. Maini.
The CoreValve System was approved by the U.S. Food and Drug Administration (FDA) in January 2014 for patients considered extreme risk for surgery. The device is not currently approved in the U.S. for use with patients at high risk. PinnacleHealth was actively involved in the extreme risk and high-risk trials and continues to participate in further research for those with intermediate risk.
Each year, nearly five million Americans are diagnosed with valve disease. Worldwide, approximately 300,000 people have been diagnosed with severe aortic stenosis and about one-third of this group has been found at too high a risk for traditional valve surgery. The CoreValve System is designed to provide a minimally invasive treatment option for patients with symptomatic, severe aortic valve stenosis.
"The results of this study are transforming the way we treat aortic stenosis. To participate in this trial and be a part of this revolutionary shift in medicine is exciting, but the true winners are our patients who will benefit from evidence-based medicine as we move forward," states Mubashir Mumtaz, MD, FACS, surgical director of the PinnacleHealth Heart Valve Clinic.
Primarily affecting the older population, aortic stenosis is a condition of the aortic valve that keeps the valve from opening and closing properly. This restricts healthy blood flow from the aorta to the rest of the body. While the heart initially compensates for stenosis by thickening its walls to help push blood through the valve, eventually this extra work weakens the heart and leads to an insufficient supply of oxygen-rich blood.
Symptoms of aortic valve stenosis can include fatigue, dizziness, chest pain or pressure, heart murmur, shortness of breath during activity, heart palpitations and fainting. Untreated, aortic valve stenosis can lead to serious heart problems including heart failure and even death. According to research, without effective treatment, as many as 50 percent of aortic stenosis patients with severe symptoms die within one year.
Media Contact: Kelly McCall, PinnacleHealth System, 717-231-8104, [email protected]
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SOURCE PinnacleHealth System